At a glance
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A Randomized Clinical Trial of Single Dose Liposomal Bupivacaine Delivered Via VATS Intercostal Nerve Block vs. Continuous Bupivacaine Infusion Delivered Via Indwelling Subscapular Catheter After Surgical Stabilization of Rib Fractures
In Brief
A Phase 4 clinical trial evaluating Liposomal bupivacaine injection and Bupivacaine indwelling catheter for Drug Effect and 11 related conditions. Completed, enrolled 36 participants across 1 site.
Detailed Summary
Rib fractures represent a common injury pattern this is highly associated with patient morbidity and mortality, as pain control remains a challenge. Even after surgical stabilization of rib fractures (SSRF), unsuccessful pain control can lead to morbid outcomes such as pneumonia and opioid dependence. Multi-modal anesthesia, with the use of thoracic epidurals and para-vertebral injections/catheters, has shown to lessen these occurrences but are subject to a wide array of limitations. A more directed therapy with liposomal bupivacaine has shown to provide sustained analgesia for up to 72 hours in patients who have undergone other types of thoracic surgery, but not SSRF. The hypothesis of the current clinical trial is that, among patients undergoing SSRF, liposomal bupivacaine delivered via video assisted thoracic surgery (VATS) is an intercostal nerve block that provides comparable analgesia to the pain catheter, as measured by pulmonary function, numeric pain scoring, and postoperative narcotic use.
Study Details
Timeline
Interventions
A single injection of liposomal bupivacaine is administered at the time of SSRF, directly to the fracture site via VATS
Bupivacaine indwelling OnQ pain pump catheter is placed in the subscapular space at the time of SSRF for continuous bupivacaine infusion post op